BEUDAMED
    FDA Adverse Event Death Summary report: N

    NGEN GENERATOR

    MDR report key: 20519231 · Received October 23, 2024

    Report

    Report Number
    2029046-2024-03463
    Event Type
    Death
    Date Received
    October 23, 2024
    Date of Event
    September 9, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835018073
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. NOTE: PER FDA REQUEST, MDR SUBMISSIONS FOR THE NGEN RF GENERATOR ARE TO BE REPORTED WITH PMA DETAILS OF THE CATHETER USED ALONG WITH THE NGEN RF GENERATOR. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) AND POSTERIOR WALL ABLATION PROCEDURE WITH A QDOT MICRO AND A NGEN GENERATOR AND THE PATIENT EXPERIENCED ATRIO-ESOPHAGEAL FISTULA / PERFORATION THAT LED TO SEPSIS AND CEREBRAL INFARCTION. THE PATIENT DIED. ON SEPTEMBER 9TH, ABLATION WAS PERFORMED AT MIE HEART CENTER (PVI + POSTERIOR WALL ISOLATION), NO ISSUE WAS FOUND DURING THE PROCEDURE. ON SEPTEMBER 23TH, THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL DUE TO UNSTABLE VITAL SIGNS. ON SEPTEMBER 24TH, THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL DUE TO IMPAIRED CONSCIOUSNESS. ON COMPUTED TOMOGRAPHY (CT), ESOPHAGEAL PERFORATION AND MEDIASTINAL EMPHYSEMA WERE CONFIRMED, SO THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL. ON SEPTEMBER 29TH, THE PATIENT'S CONDITION WORSENED AND HE DIED OF SEPSIS AND CEREBRAL INFARCTION. DEVICE INVESTIGATION DETAILS: REPAIR FOLLOW-UP WAS PERFORMED AS THE DEVICE WAS NOT SHIPPED FOR SERVICE OR REPAIR. PER THE CUSTOMER, SERVICE WAS NOT NEEDED. SERVICE WAS DECLINED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 24-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING A STATEMENT PREVIOUSLY REPORTED IN SECTION B5. EVENT DESCRIPTION OF THE 3500A INITIAL MEDWATCH. WHAT THEY MEANT WAS, "IT IS CURRENTLY UNKNOWN WHAT FACTORS, INCLUDING ANATOMICAL STRUCTURES OF THE VERTEBRAE, ETC., MAY HAVE CONTRIBUTED TO THE EVENT.¿ IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) AND POSTERIOR WALL ABLATION PROCEDURE WITH A QDOT MICRO AND A NGEN GENERATOR AND THE PATIENT EXPERIENCED ATRIO-ESOPHAGEAL FISTULA / PERFORATION THAT LED TO SEPSIS AND CEREBRAL INFARCTION. THE PATIENT DIED. ON (B)(6), ABLATION WAS PERFORMED AT MIE HEART CENTER (PVI + POSTERIOR WALL ISOLATION), NO ISSUE WAS FOUND DURING THE PROCEDURE. ON (B)(6), THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL DUE TO UNSTABLE VITAL SIGNS. ON (B)(6), THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL DUE TO IMPAIRED CONSCIOUSNESS. ON COMPUTED TOMOGRAPHY (CT), ESOPHAGEAL PERFORATION AND MEDIASTINAL EMPHYSEMA WERE CONFIRMED, SO THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL. ON (B)(6), THE PATIENT'S CONDITION WORSENED AND HE DIED OF SEPSIS AND CEREBRAL INFARCTION. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT IS THAT THERE WERE NO DEFECTIVE PRODUCTS AND THAT IT IS POSSIBLE THAT THE FACT THAT THE AREA NEAR THE ESOPHAGUS WAS ABLATED TWICE WITH 90W WITH THE QDOT MICRO CATHETER HAD AN EFFECT, BUT THE DIRECT CAUSE IS CURRENTLY UNKNOWN. THE PHYSICIAN REPORTED THAT THE EFFECT ON THE ESOPHAGUS WAS RATHER CONSIDERED AND VHPSD (HIGH POWER SHORT DURATION) WAS FELT TO BE SAFE. THEREFORE, SHORT TERM POWER SUPPLY + SKIP POWER SUPPLY (TO PREVENT CONTINUOUS POWER SUPPLY AROUND ESOPHAGUS) WAS APPLIED WHILE CONTACT FORCE (CF) WAS SUPPRESSED. THEREFORE, IT WAS NOT BECAUSE OF THE HIGH OUTPUT POWER OR ANYTHING LIKE THAT. AT THE MOMENT, IT IS UNCLEAR "WHAT AFFECTED THE VERTEBRAL BODY", INCLUDING THE ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375201 NGEN GENERATOR CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 10846835018073

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Death 10439011| 7FR,DEF,15MM DIA., CCW,LASSO| NGEN PUMP, JAPAN CONFIGURATION| OCTA,STD,48P,2-2-2-2-2,D-CURVE| QDOT MICRO, BI, TC, D-F| UNK_CARTO 3